The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Reads(r) Anti-ena (sm/rnp) Test Kit.
| Device ID | K901924 |
| 510k Number | K901924 |
| Device Name: | READS(R) ANTI-ENA (SM/RNP) TEST KIT |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 5766 CENTRAL AVE. FLATIRON INDUSTRIAL PARK Boulder, CO 80301 |
| Contact | Nancy Sauer |
| Correspondent | Nancy Sauer BIOSEARCH MEDICAL PRODUCTS, INC. 5766 CENTRAL AVE. FLATIRON INDUSTRIAL PARK Boulder, CO 80301 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-30 |
| Decision Date | 1990-05-09 |